2.2. Supplier Management
The process for the evaluation, selection and re-evaluation of suppliers providing completed devices, components, materials, accessory devices, and global cloud services to ensure all the products and services meet the specifications.
Processes and requirements for selecting, evaluating, and monitoring suppliers and subcontractors.
The process of assessing, approving and re-assessing approved suppliers to ensure they continue to meet the established qualification criteria.
Systematic, planned, and documented assessments conducted by the medical device manufacturer (or their representative) to evaluate a supplier's ability to meet the specified requirements.
Procedures used to address any issues or nonconformances identified with a supplier's performance.
Documented record of suppliers that have been evaluated, qualified, and approved by the medical device manufacturer.
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Processes and procedures used to oversee the suppliers that are responsible for distributing or importing the medical device.
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Defining and implementing key performance indicators (KPIs) to measure and monitor the performance of the approved suppliers.
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Evaluation of a supplier's ability to meet the current and future production demands.
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Periodic assessment and review of approved suppliers to ensure they continue to meet the medical device manufacturer's requirements.
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Ongoing activities and systems used to track, evaluate, and maintain oversight of approved suppliers.
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Managing and controlling changes to the approved suppliers or the materials/components they provide.
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Maintenance of the Approval Supplier List (see above).